$573 million in third quarter global net product
sales
CIDP global expansion on track, with decisions on
approval under review in Japan, Europe, China, and Canada
Management to host conference call today at 1:30
PM CET (8:30 AM ET)
Regulated information - Inside
information
October 31, 2024 7:00AM CET
Amsterdam, the Netherlands –
argenx SE (Euronext & Nasdaq: ARGX), a global immunology
company committed to improving the lives of people suffering from
severe autoimmune diseases, today announced its third quarter 2024
financial results and provided a business update.
“We delivered significant patient impact with
VYVGART over the quarter, expanding our gMG footprint and
delivering innovation to CIDP patients three months into launch,”
said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We
continued to advance our goal of reaching more gMG patients earlier
in their treatment journey, supported by VYVGART’s strong safety
and efficacy profile, and real-world data showing the ability to
meaningfully reduce steroid use. Expanding upon our leadership in
gMG, we are now paving the future in CIDP. The strength of our
data, combined with execution across the team to reach key
stakeholders, contributed to the initial success of our CIDP
launch, with more than 300 patients on therapy at the end of the
third quarter. There remains significant opportunity ahead as we
work towards achieving our Vision 2030, with innovation implemented
across our pipeline to deliver transformative outcomes to more
patients.”
Advancing ‘Vision 2030’ in Third Quarter
2024
Vision 2030 is the next phase in argenx’s
long-term commitment to transform the treatment of autoimmune
diseases by strengthening its leadership in FcRn biology, investing
in its continuous pipeline of differentiated antibody candidates,
and scaling in a disciplined way to ensure innovation remains core
to the argenx mission. As a part of this vision, argenx plans to
reach at least 50,000 patients globally, advance the pipeline to
achieve 10 labeled indications, and bring five new molecules into
Phase 3 by 2030.
Reaching 50,000 Patients Globally by
2030
VYVGART® (efgartigimod alfa-fcab) is a
first-in-class antibody fragment targeting FcRn and is now approved
for both intravenous use and subcutaneous injection (SC)
(efgartigimod alfa and hyaluronidase-qvfc) in three indications,
including generalized myasthenia gravis (gMG) globally, primary
immune thrombocytopenia (ITP) in Japan (IV only), and chronic
inflammatory demyelinating polyneuropathy (CIDP) in the U.S. (SC
only).
- Generated global
net product revenues (inclusive of both VYVGART and VYVGART SC) of
$573 million in the third quarter of 2024
- Multiple VYVGART
regulatory submissions completed or underway for gMG, including:
- Swissmedic approved
VYVGART for the treatment of gMG in Switzerland
- Regulatory
decisions on approval expected in Australia and Saudi Arabia in
2024, and South Korea in 2025
- Multiple VYVGART SC
regulatory submissions under review or planned for CIDP, including:
- Regulatory
submissions completed in Japan, Europe, and China with decisions on
approval expected in 2025
- Regulatory
submission to be completed in Canada by end of 2024
- VYVGART now
reimbursed in 11 countries in Europe, with new agreements in place
in France, Luxembourg, and Belgium
- FDA review of
VYVGART SC pre-filled syringe (PFS) for gMG and CIDP ongoing with
Prescription Drug User Fee Act (PDUFA) target action date of April
10, 2025
Advancing Pipeline to Achieve 10 Labeled
Indications by 2030
argenx continues to demonstrate breadth and
depth within its immunology pipeline, advancing multiple
pipeline-in-a-product candidates. argenx is solidifying its
leadership in FcRn biology, with efgartigimod currently in
development in 15 indications. argenx is also advancing its
first-in-class C2 inhibitor, empasiprubart, which is being
evaluated in multifocal motor neuropathy (MMN), delayed graft
function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx
is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in
both congenital myasthenic syndrome (CMS) and amyotrophic lateral
sclerosis (ALS).
- Registrational
studies ongoing of efgartigimod in thyroid eye disease (TED)
- Registrational
studies ongoing to support label-expansion into broader MG,
including ADAPT SERON in seronegative gMG and ADAPT OCULUS in
ocular MG
- Registrational
study in primary Sjögren’s disease (SjD) on track to start by end
of 2024
- Confirmatory study
of efgartigimod in primary ITP to start by end of 2024 to enable
registration in U.S.
- Topline data from
seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across
three myositis subsets (immune-mediated necrotizing myopathy
(IMNM), anti-synthetase syndrome (ASyS), and DM) expected by end of
2024
- Update on BALLAD
study development plan evaluating efgartigimod in bullous
pemphigoid (BP) expected by end of 2024
- Decision made to
discontinue development of efgartigimod in membranous nephropathy
(MN); proof-of concept study ongoing with efgartigimod in lupus
nephritis (LN)
- Proof-of-concept
study ongoing with efgartigimod in antibody mediated rejection
(AMR), with systemic sclerosis (SSc) to start by end of 2024
- Registrational
study of empasiprubart in MMN to start by end of 2024
- Additional
proof-of-concept studies of empasiprubart ongoing, including
VARVARA study in DGF and EMPACIFIC study in DM
- Registrational
study of empasiprubart in CIDP to start in 2025
- Ongoing Phase 1b/2a
studies of ARGX-119 to assess early signal in patients with CMS and
ALS
Investing in Immunology Innovation
Program to Support Five New Molecules in Phase 3 by
2030
argenx continues to invest in its Immunology
Innovation Program (IIP) to drive long-term sustainable pipeline
growth. Through the IIP, four new pipeline candidates have been
nominated, including: ARGX-213, targeting FcRn and further
solidifying argenx’s leadership in this new class of medicine;
ARGX-121, a first-in-class molecule targeting IgA; ARGX-109,
targeting IL-6, which plays an important role in inflammation, and
ARGX-220, a first-in-class sweeping antibody for which the target
has not yet been disclosed.
- Phase 1 studies of
ARGX-213 and ARGX-121 expected to start in second half of 2025
- Investigational new
drug (IND) applications for ARGX-220 and ARGX-109 on track to be
filed by end of 2025
THIRD QUARTER 2024 FINANCIAL
RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM
STATEMENTS OF PROFIT OR LOSS
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30 |
|
September 30 |
(in thousands of $ except for shares and EPS) |
|
2024 |
|
2023 |
|
2024 |
|
|
2023 |
Product net sales |
|
$ |
572,997 |
|
$ |
329,097 |
|
$ |
1,448,915 |
|
$ |
816,432 |
Collaboration revenue |
|
|
239 |
|
|
692 |
|
|
2,905 |
|
|
3,047 |
Other operating income |
|
|
15,642 |
|
|
10,050 |
|
|
38,999 |
|
|
31,275 |
Total operating
income |
|
$ |
588,878 |
|
$ |
339,839 |
|
$ |
1,490,819 |
|
$ |
850,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
$ |
(59,072) |
|
$ |
(35,999) |
|
$ |
(154,633) |
|
$ |
(78,358) |
Research and development
expenses |
|
|
(235,940) |
|
|
(191,755) |
|
|
(686,195) |
|
|
(553,119) |
Selling, general and
administrative expenses |
|
|
(277,698) |
|
|
(191,930) |
|
|
(769,392) |
|
|
(503,079) |
Loss from investment in a
joint venture |
|
|
(1,981) |
|
|
(743) |
|
|
(5,294) |
|
|
(2,623) |
Total operating
expenses |
|
$ |
(574,691) |
|
$ |
(420,427) |
|
$ |
(1,615,514) |
|
$ |
(1,137,179) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
profit/(loss) |
|
$ |
14,187 |
|
$ |
(80,588) |
|
$ |
(124,695) |
|
$ |
(286,425) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income |
|
$ |
40,586 |
|
$ |
30,049 |
|
$ |
118,414 |
|
$ |
67,078 |
Financial expense |
|
|
(676) |
|
|
(231) |
|
|
(1,760) |
|
|
(626) |
Exchange gains/(losses) |
|
|
33,927 |
|
|
(32,509) |
|
|
6,712 |
|
|
(23,345) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit/(loss) for the
period before taxes |
|
$ |
88,024 |
|
$ |
(83,279) |
|
$ |
(1,329) |
|
$ |
(243,318) |
Income tax
(expense)/benefit |
|
$ |
3,386 |
|
$ |
10,637 |
|
$ |
60,208 |
|
$ |
47,437 |
Profit/(loss) for the
period |
|
$ |
91,410 |
|
$ |
(72,642) |
|
$ |
58,879 |
|
$ |
(195,881) |
Profit/(loss) for the period
attributable to: |
|
|
|
|
|
|
|
|
|
|
|
|
Owners of the parent |
|
$ |
91,410 |
|
$ |
(72,642) |
|
$ |
58,879 |
|
$ |
(195,881) |
Weighted average number of
shares outstanding |
|
|
60,087,498 |
|
|
58,128,233 |
|
|
59,633,179 |
|
|
56,512,254 |
Basic profit/(loss) per share
(in $) |
|
|
1.52 |
|
|
(1.25) |
|
|
0.99 |
|
|
(3.47) |
Diluted profit/(loss) per
share (in $) |
|
|
1.39 |
|
|
(1.25) |
|
|
0.91 |
|
|
(3.47) |
Net increase in cash, cash
equivalents and current financial assets compared to year-end 2023
and 2022 |
|
|
|
|
|
|
|
$ |
194,523 |
|
$ |
993,035 |
Cash and cash equivalents and
current financial assets at the end of the period |
|
|
|
|
|
|
|
$ |
3,374,367 |
|
$ |
3,185,583 |
DETAILS OF THE FINANCIAL
RESULTS
Total operating income for the
third quarter and year-to-date in 2024 was $589 million and $1,491
million, respectively, compared to $340 million and $851 million
for the same periods in 2023, and mainly consists of:
- Product net sales
of VYVGART for the three months ended and nine months ended
September 30, 2024, were $573 million and $1,449 million,
compared to $329 million and $816 million for the same periods in
2023.
- Other operating
income for the third quarter and year-to-date in 2024 was
$16 million and $39 million, respectively, compared to $10 million,
and $31 million for the same periods in 2023. The other operating
income for the three and nine months ended September 30, 2024
primarily relates to research and development tax incentives and
payroll tax rebates.
Total operating expenses for
the third quarter and year-to-date in 2024 were $575 million and
$1,616 million, respectively, compared to $420 million and $1,137
million for the same periods in 2023, and mainly consists of:
- Cost of sales for
the third quarter and year-to-date in 2024 was $59 million and $155
million, respectively, compared to $36 million and $78 million for
the same periods in 2023. The cost of sales was recognized with
respect to the sale of VYVGART and VYVGART Hytrulo.
- Research and development
expenses for the third quarter and year-to-date in 2024
were $236 million and $686 million, respectively, compared to $192
million and $553 million for the same periods in 2023. The research
and development expenses mainly relate to external research and
development expenses and personnel expenses incurred in the
clinical development of efgartigimod in various indications and the
expansion of other clinical and preclinical pipeline
candidates.
- Selling, general and
administrative expenses for the third quarter and
year-to-date in 2024 were $278 million and $769 million,
respectively, compared to $192 million and $503 million for the
same periods in 2023. The selling, general and administrative
expenses mainly relate to professional and marketing fees linked to
global commercialization of VYVGART and VYVGART Hytrulo, and
personnel expenses.
Financial income for the third
quarter and year-to-date in 2024 was $41 million and $118 million,
respectively, compared to $30 million and $67 million for the same
periods in 2023. The increase in financial income is mainly due to
an increase in interest income on current financial assets and cash
and cash equivalents.
Exchange gains for the third
quarter and year-to-date in 2024 were $34 million and $7 million
respectively, respectively, compared to $(33) million and $(23)
million of exchange losses for the same periods in 2023. Exchange
gains/losses are mainly attributable to unrealized exchange rate
gains or losses on the cash, cash equivalents and current financial
assets position in Euro.
Income tax for the third
quarter and year-to-date in 2024 was $3 million and $60 million of
tax benefit, respectively, compared to $11 million and $47 million
of tax benefit for the same periods in 2023. Tax benefit for the
nine months ended September 30, 2024 consists of $29 million
of income tax expense and $89 million of deferred tax income,
compared to $24 million of income tax expense and $71 million of
deferred tax income for the comparable prior period.
Net income for the three and
nine month periods ended September 30, 2024, was $91 million
and $59 million, respectively, compared to a net loss of $(73)
million and $(196) million over the prior year periods. On a per
weighted average share basis, the earnings per share was $0.99 for
the nine months ended September 30, 2024 and a net loss per
share of $(3.47) for the nine months ended September 30,
2023.
Cash, cash equivalents and current
financial assets totaled $3.4 billion as of
September 30, 2024, compared to $3.2 billion as of December
31, 2023. The increases in cash and cash equivalents and current
financial assets over the period was from financing activities due
to the exercise of stock options which is offset by net cash flows
used in operating and investing activities.
FINANCIAL GUIDANCE
With the increase in cash, cash equivalents and current
financial assets in the quarter and year-to-date, the previously
issued cash guidance no longer applies. The financial guidance on
the combined selling, general and administrative expenses and
research and development expenses remains unchanged at
approximately $2 billion.
EXPECTED 2024 FINANCIAL
CALENDAR
- February 27, 2025: Full-year 2024
financial results and 4Q 2024 business update
CONFERENCE CALL DETAILS
The third quarter 2024 financial results and
business update will be discussed during a conference call and
webcast presentation today at 1:30 pm CET/8:30 am ET. A webcast of
the live call and replay may be accessed on the Investors section
of the argenx website at argenx.com/investors.
Dial-in numbers:
Please dial in 15 minutes prior to the live
call.
Belgium 32
800 50
201France 33
800
943355Netherlands 31
20 795 1090United
Kingdom 44
800 358 0970United States
1
888 415
4250Japan 81
3 4578
9081Switzerland 41
43 210 11 32
About argenx
argenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases. Partnering with leading academic researchers through its
Immunology Innovation Program (IIP), argenx aims to translate
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. argenx developed and is commercializing
the first approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK, China and Canada. The Company is
evaluating efgartigimod in multiple serious autoimmune diseases and
advancing several earlier stage experimental medicines within its
therapeutic franchises. For more information, visit www.argenx.com,
and follow us on LinkedIn,
X/Twitter, Instagram, Facebook, and YouTube.
For further information, please
contact:
Media:
Ben Petokbpetok@argenx.com
Investors:Alexandra Roy (US)aroy@argenx.com
Lynn Elton (EU)lelton@argenx.com
Forward-looking Statements
The contents of this announcement include
statements that are, or may be deemed to be, “forward-looking
statements.” These forward-looking statements can be identified by
the use of forward-looking terminology, including the terms “aim,”
“achieve,” “advance,” “bring,” “complete,” “expect,” “initiate,”
“plan,” “reach,” “start,” “support,” “to be,” or “will,” and
include statements argenx makes regarding its goal to reach more
gMG patients in an early-line setting; its growth opportunity; its
Vision 2030 plan, including (1) transforming the treatment of
autoimmune diseases by strengthening its leadership in FcRn
biology, (2) investing in its continuous pipeline of differentiated
antibody candidates, (3) scaling in a disciplined way to ensure
innovation, and (4) reaching 50,000 patients globally with an
argenx medicine, 10 labeled indications across all approved assets,
and five new molecules in Phase 3 development; the advancement of
anticipated clinical development, data readouts and regulatory
milestones and plans, including (1) the anticipated timing of
additional VYVGART regulatory decisions on approval for gMG in
Australia, Saudi Arabia, and South Korea, (2) the anticipated
timing of VYVGART SC regulatory submissions for CIDP, including
decisions on approval in China, Japan, and Europe and an
anticipated regulatory submission filing in Canada, (3) the
anticipated timing of the initiation of a registrational study for
efgartigimod in primary SjD, (4) the anticipated timing of a
confirmatory study of efgartigimod in primary ITP, (5) the
anticipated timing of topline data from Phase 2/3 ALKIVIA study
evaluating efgartigimod across three myositis subsets, (6) the
anticipated timing of an update on the BALLAD study development
plan evaluating efgartigimod in BP, (7) the anticipated timing of
proof-of-concept study data for efgartigimod in LN, (8) the
anticipated timing of the initiation of a study on efgartimod in
SSc, (9) the anticipated timing of the initiation of a
registrational study of empasiprubart for MMN, (9) the anticipated
timing of the initiation of a registrational study of empasiprubart
in CIDP, (10) the anticipated timing of the initiation of Phase 1
studies of ARGX-213 and ARGX-121, (11) the anticipated timing of
the filing of investigational new drug applications for ARGX-220
and ARGX-109; the advancement of empasiprubart; its 2024 selling,
general and administrative expenses and research and development
expenses; the anticipated timing of releases of future financial
results and business updates; and its goal of translating
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. By their nature, forward-looking
statements involve risks and uncertainties and readers are
cautioned that any such forward-looking statements are not
guarantees of future performance. argenx’s actual results may
differ materially from those predicted by the forward-looking
statements as a result of various important factors, including the
results of argenx's clinical trials; expectations regarding the
inherent uncertainties associated with the development of novel
drug therapies; preclinical and clinical trial and product
development activities and regulatory approval requirements in
products and product candidates; the acceptance of argenx's
products and product candidates by patients as safe, effective and
cost-effective; the impact of governmental laws and regulations on
our business; disruptions caused on our reliance of third parties
suppliers, service provides and manufacturing; inflation and
deflation and the corresponding fluctuations in interest rates; and
regional instability and conflicts. A further list and description
of these risks, uncertainties and other risks can be found in
argenx’s U.S. Securities and Exchange Commission (SEC) filings and
reports, including in argenx’s most recent annual report on Form
20-F filed with the SEC as well as subsequent filings and reports
filed by argenx with the SEC. Given these uncertainties, the reader
is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. argenx undertakes no
obligation to publicly update or revise the information in this
press release, including any forward-looking statements, except as
may be required by law.
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